Sustained Release Oral Formulation for Parkinson's Disease
What You Need to Know Before You Apply
What is the purpose of this trial?
LD/CD (medications to treat Parkinson's disease) will be delivered using an assembly of nested sachets made of permeable material. The assembly is placed in the oral/buccal cavity (between cheek and gum of lower jaw) and delivers continuous release of CD and LD for both transmucosal and gastrointestinal absorption. The combination of CD/LD in the inner sachet varies from that in the outer sachet. This allows for sequential release of CD and then LD to mimic a CD pretreatment method which is known to increase LD absorption and prolong its half-life.
Who Is on the Research Team?
Khalaf Bushara, MD, FRCP
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for people diagnosed with Parkinson's disease as well as healthy volunteers. Participants should be able to use oral medications and not have any conditions that would interfere with the study or its results.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single dose of CD/LD using a novel delivery method for pharmacokinetic analysis
Follow-up
Participants are monitored for safety and pharmacokinetic outcomes after administration
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests three new oral formulations (A, B, and C) of Parkinson’s medications (CD/LD) using special sachets placed between the cheek and gum. These provide a steady release of medicine to improve absorption and effects compared to standard treatments.
How Is the Trial Designed?
3
Treatment groups
Active Control
Two sachets nested between the lower jaw, gum, and cheek; outer sachet 100 mg CD/0mg LD and inner sachet 0mg CD /400mg LD
Two sachets nested between the lower jaw, gum, and cheek; outer sachet 200mg CD/0mg LD and inner sachet 800mg LD
Two sachets nested between the lower jaw, gum, and cheek; outer sachet 150mg CD/0mg LD and inner sachet 600mg LD
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
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